Cleared Special

K131009 - PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K131009 · Proteus Digital Health, Inc. · Gastroenterology & Urology device
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May 2013
Decision
26d
Days
Class 2
Risk

K131009 is an FDA 510(k) clearance for the PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY). Classified as Ingestible Event Marker (product code OZW), Class II - Special Controls.

Submitted by Proteus Digital Health, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 7, 2013 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 880.6305 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Proteus Digital Health, Inc. devices

Submission Details

510(k) Number K131009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2013
Decision Date May 07, 2013
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OZW Ingestible Event Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6305
Definition To Provide Confirmation Of An Event Co-ingested Or Coincident With The Ingestible Component Of The Device. The Wearable Component Of The Device Incorporates Wireless Communication To Display The Event And Other Information On A General Computing Device
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.